Research Moratoria

Moratoria, temporary prohibitions on specific forms of research, are one of the most prominent tools of scientific self-governance. When a research controversy rears its head, many in the scientific community are quick to call for a time-limited and voluntary ban on the research in question.

“Clinical germline editing should not proceed for any application without broad societal consensus on the appropriateness of altering a fundamental aspect of humanity for a particular purpose. Unless a wide range of voices are equitably engaged from the outset, efforts will lack legitimacy and might backfire” (Lander et al. 2019: 167).

These calls often reference the legacy of a specific moratorium success story: the Congress on Recombinant DNA Molecules, held in 1975 at the Asilomar Conference Grounds in Pacific Grove, California. Scientists convened at Asilomar after calling for a worldwide moratorium in response to the emergence of recombinant DNA technology and its as-yet unknown consequences. At Asilomar, the scientists determined that such research would be allowed to proceed, but proposed strict guidelines to manage risk.

Those who regard Asilomar—as the gathering is commonly called—as a triumph of scientific self-governance call on scientists’ foresight and wisdom to impose restrictions on themselves, the wide observance of the moratorium, and the way in which it ultimately produced a consensus that allowed research to proceed safely and without significant controversy. This selective memory of Asilomar emphasizes consensus while downplaying the uncertainty and contentiousness that both surrounded and succeeded it.

Many in the research community have now called for a moratorium-pending-consensus on human germline genome editing. In light of such calls, it is worth emphasizing how moratoria have historically narrowed the scope of public participation in deliberations of emerging technologies and consolidated the authority to govern scientific research among research scientists. Their effect is usually that the scientific community declares the end of controversy, and research forges ahead.

Introduction: CRISPR-baby Controversy

He Jiankui at the Second International Summit on Human Genome EditingIn 2018, at the Second Annual Summit on Human Gene Editing, it became public that He Jiankui’s CRISPR/Cas9 experiments had resulted in the birth of two gene-edited infants. The backlash from the international scientific community was swift. Eric Lander, founding Director of the Broad Institute of MIT and Harvard, and an expansive list of coauthors publicly called for a global moratorium on human germline editing. The National Institutes of Health (NIH), the US National Academies of Sciences and Medicine, and the UK’s Royal Society immediately threw their support behind the call. Lander et al. acknowledged that such a moratorium “would place major speed bumps in front of the most adventurous plans to re-engineer the human species” (2019:168) but regarded the alternate potentials of harm to patients and the erosion of public trust more dangerous.

Much of the legacy of moratoria on biotechnology research can be traced to 1974, when leading American molecular biologists called for a voluntary moratorium on the use of recombinant DNA technology. The following year, these researchers organized a meeting at the Asilomar Conference Grounds in Pacific Grove, CA. At Asilomar, as summarized by the researchers themselves, those gathered discussed scientific progress on recombinant DNA techniques and weighed whether the voluntary moratorium should end. Despite the many unknowns surrounding the technologies and their applications and effects, the researchers concluded that “most of the work on construction of recombinant DNA molecules should proceed provided that appropriate safeguards… are employed.” The researchers focused on technical procedures of risk and containment as these “appropriate safeguards” and in doing so, positioned scientists themselves as the proper authorities to govern research and decide its appropriate limits.

This meeting and its legacy still loom large and serve as touchstones in debates over the application of moratoria and the responsible governance of science and technology, including calls for a moratorium on human germline genome editing. The legacy often attributed to Asilomar—as it is simply and commonly called—is that of a model success of scientific restraint and self-regulation and of public participation in the governance of new technologies. However, this model can both distort the realities of Asilomar and, more importantly, constrain and impoverish our collective imaginaries of scientific governance.

Moratoria (In)Action

Between Asilomar and the 2018 reveal of “CRISPR-babies” Lulu and Nana, members of the scientific community proposed or pondered research moratoria in several different biotechnology contexts where potential controversy loomed. Examples included the creation and dissemination of recombinant agricultural organisms, the prospects of human cloning and xenotransplantation, research on certain stages of embryonic development (see the Observatory's collection on the 14-Day Rule), the administration of (non-germline) gene therapy, and—in what has become a hotly contested issue in the wake of the global pandemic—the pursuit of gain-of-function research in pathogenic organisms.

Within the research community, moratoria have often been controversial themselves. There have been significant debates and conflicts over when moratoria might be necessary, what such moratoria should cover, and what the preferred mechanisms of enforcement are. As one example, the United States, Canada, and Argentina called on the World Trade Organization (WTO) to challenge the EU’s de facto moratorium on the importation of genetically modified foods. The WTO’s decision to uphold the complaint that such a moratorium was illegal failed to account for the contextual and socially constructed nature of risk/benefit analysis. In this case, a legal moratorium founded in part on the European public’s distrust of genetically engineered organisms was overruled, establishing a very American and very technical form of decision-making in global technology governance. As an example, it indicates how legal moratoria—even de facto legal moratoria—may face challenges on the grounds that technological governance should be based on scientific and technical expertise.

In debates around moratoria, the scientific community has tended to favor voluntary over legal moratoria, though researchers are often wary of all moratoria and how they could limit their activities. Despite this wariness, some researchers turn to calls for voluntary restraint to preempt threats of legal moratoria and to uphold Asilomar’s legacy of scientific self-governance. However, such calls remain divisive, and their divisiveness in the research community has already produced effects in the area of human germline genome editing.

There were early rumblings of a moratorium on human germline genome editing beginning around 2015, in the wake of the development of the gene-editing tool CRISPR/Cas9. Two of the scientists responsible for the Asilomar conference, David Baltimore and Paul Berg, notably voiced support for these early calls. Looking back forty years, the elder statesmen noted of Asilomar that “although somatic-gene therapy was viewed at that time as having become possible, the prospect for germ-line therapy seemed so far in the future that it was not seriously discussed.” They suggested that the recent development of CRISPR/Cas9 indicated the time had come. Around the same time, Baltimore and Berg were chief among a group of 18 scientists who gathered in Napa, California to discuss the emerging potential of CRISPR/Cas9 for human germline genome editing. In Science, these researchers called for discouraging such applications to allow time for open discussion between researchers, bioethicists, government agencies, and members of the public.
The rumblings grew louder after the publication of CRISPR research on nonviable human embryos that same year prompted the US National Academies of Sciences and Medicine to organize an International Summit on Human Gene Editing. The formal statement released in its wake declared that “it would be irresponsible to proceed with any clinical use of germline editing unless and until: (i) the relevant safety and ethical issues have been resolved… and (ii) there is broad societal consensus about the appropriateness of the proposed application.” However, the statement did not invoke the word moratorium, a decision philosopher and bioethicist Françoise Baylis attributes to fear among committee members that specifically declaring a moratorium would signal a permanent research ban. This reluctance to declare a moratorium left the door open to softening guidance. An expert committee convened by the US National Academies of Sciences and Medicine released a report just over a year later that laid out criteria for acceptable applications of human germline editing research. He Jiankui specifically referenced this report in a form he submitted for his CRISPR experiments. Baylis draws on Global Observatory Co-Director Ben Hurlbut to argue that it is quite possible that if the word moratorium had been used in the National Academies’ 2015 statement, He’s experiments would not have taken place.

But take place they did, and in the wake of the public reveal of He Jiankui’s experiments, Eric Lander and his colleagues did invoke the word moratorium in their calls for a temporary prohibition on human germline editing research. In the aftermath, as many members of the scientific community weighed in on the proposal, they often drew on the legacy of Asilomar and the intervening examples of proposed and actual moratoria on biotechnological research. Like Baltimore and Berg, many within the scientific research community attempted to follow what they characterized as Asilomar’s example of scientific self-governance, temporary restraint, and risk- and safety-based analysis.

Moratoria’s Imagined Effects

The prospect of a moratorium on human germline genome editing continues to split the research community as the fear of a blanket research ban persists. Critics object that moratoria are blunt instruments that slow research or drive it underground, impose ideology on science (and are therefore “unscientific”), have unintended effects, and are simply unnecessary given past examples of scientific restraint. Jennifer Doudna, who would become a recipient of a 2020 Nobel Prize in chemistry for her role in the development of CRISPR/Cas9, has argued that moratoria are inadequate while applauding the efforts of the World Health Organization (WHO) and leading science advisory bodies to establish guidance. Even Lander and others favoring a moratorium have argued against an imposition with legal force behind it, instead favoring a voluntary, temporary prohibition. Whatever their disagreements, these divided groups broadly agree on the scientific research community’s ability to responsibly self-govern, determining how best to proceed.

This agreement, however, is based on a rather narrow interpretation of Asilomar’s legacy and the historic effects of research moratoria. Even at the time of Asilomar, some researchers regarded research freedom as a moral absolute, and others objected to invoking the word moratorium on the grounds that it sounded “‘too officious’” and severe. Researchers also disagreed about which types of experimental research should be halted. In negotiating disagreements within the research community, scientists took an approach to risk that largely allowed scientists to avoid responsibility for managing uncertainty and demonstrating the safety of their work. Instead it required that hypothetical risks be demonstrated as plausible in order to be taken seriously. Nor did controversy simply disappear after Asilomar. For example, environmental groups became heavily concerned with representation and decision-making around transgenic organisms.
The approach that researchers took to manage conflict and uncertainty and the subsequent interpretation of Asilomar’s legacy both enact a theory of scientific governance: the only safe and effective governance of scientific research is self-governance by technical experts, who are best able to understand the details of the technology and its associated risks and effects. Observatory Co-Director Ben Hurlbut characterizes the selective memory of Asilomar as perpetuating an imaginary of the “governable emergence” of technologies. This imaginary posits a relationship between science and the law where science and technology are the drivers of social change, while the law lags behind, relegated to merely reacting—or, as some scientists fear, overreacting by placing restrictions that limit research.

Nor do all agree that moratoria are even effective as “speed bumps” slowing scientific research to invite broader societal input. In an artistic critique of human germline editing focused around the “CRISPR babies,” bioartist Adam Zaretsky conceptualizes moratoria using a different traffic-based metaphor: “The Yellow Light of Bioethics”:

“The Yellow Light of Bioethics refers to the stalling of and threatening moratorium as a way of both representing caution for the cautious while sending a signal to speed up and make those GMO babies before the light turns red. Implicit in yellow-light ethics is that the light can turn red at any moment but hardly ever does.”

Like a yellow traffic light, Zaretsky argues, the prospect of moratoria sends a mixed signal, at once suggesting caution and acceleration. Zaretsky is therefore critical and skeptical of calls for moratoria. His argument resonates with the Global Observatory’s position that moratoria are insufficient and likely to produce little more than rationale to proceed, grounded in technical expertise and its language of risk assessment.

The Observatory’s Point of View

These alternate ways of reading the legacy of Asilomar and the history of research moratoria are enlightening. They illustrate that as tools of governance, they have typically functioned to consolidate authority over research agendas in the hands of experts in science and technology and bioethics, limiting public deliberation and conversation and ultimately allowing research to proceed. This is especially significant in cases like human germline gene editing where research has profound consequences for the public interest. It is therefore important that the question of human germline editing be not how research will proceed, but rather whether it will proceed. The former leaves little room for significant limits on research agendas. Instead, it defers to risk management frameworks that both restrict the range of valid concerns in debates over scientific research and position scientific researchers themselves as uniquely capable of governing science. It is therefore also crucial to ask who will make the decisions to proceed—or not proceed—with such research, and by what deliberative process.

It remains important to continue to collect a broader range of histories and perspectives to counter the prevailing narratives around moratoria and the governance of emerging technologies more generally. Global institutions like the World Health Organization (WHO) and International Society for Stem Cell Research (ISSCR) (link: ISSCR Guidelines) continue to take up questions related to heritable human genome editing, as do bioethics bodies like the UK’s Nuffield Council. As they do, it is vital to assert the rightful place of more cosmopolitan ethics and consensus-building in the unfolding of research agenda-setting and guidance, as a tonic to restrictive readings and the preemptive narrowing of debate.